After twelve years of legislative work, a new regulation on veterinary medicines (EU) 2019/6) becomes applicable on 28 January 2022. This is an opportune moment for us, the generic and added value veterinary medicines industry, to look back on the original objectives and to see how they have been met.
More efficiency through harmonisation and digitalisation
Being a regulation instead of a directive, the new legislation reduces room for national interpretation and brings more harmonised and predictable operating environment for our industry. The authorisation procedures are updated and brought to the digital age which increases efficiency.
The new union product database, one centralised IT system for all European veterinary medicines data, is also expected, in the long term, to reduce the amount of data input for companies. A centralised database is also good for transparency and should work as a reliable and up-to-date source of medicines information for all stakeholders, veterinarians, animal owners, regulators and pharmaceutical companies.
Great expectations on cutting red tape
The big goal of the legislators was to ease administrative burden related to auhorisations and sales of medicines both for the industry and the authorities. The Commission’s early impact assessment even showed this burden to be higher and disproportionate for the generics industry.
To our disappointment, most of the proposals to cut red tape were diluted in the process. The idea of applying risk-benefit approach in pharmacovigilance was welcome, however, the implementation itself will bring more work for the companies. At the end, we are left with a few short-term improvements in the product authorisation processes. By removing the sunset clause, an authorisation will stay valid even if the product is not on the market for three consecutive years. Also, a renewal application to prolong an authorisation after five years, is no longer needed.
Balanced competitive market
Another promise of the new legislation was to assure and increase the availability of medicines in Europe. Generic products are pivotal to this, especially in the smaller markets and for minor species. The rules remain largely complex and are unbalanced in favour of the innovators. The new protection period for an innovative product can be extended after one or more prolongations to additional animal species for up to 18 years.
This lack of transparency and clarity can prevent generic medicines from entering the market in due time and creates legal uncertainty for the generic companies. Only time will tell whether these exclusivity periods will give the intended impetus for new innovations or whether they end up becoming a protective measure. At the end, a genuinely competitive environment that nurtures innovation and brings new products to the market benefits all of us.
Enhanced tool to fight antimicrobial resistance
On the positive side, the new rules will help fight antimicrobial resistance and responsible use of antibiotics in animals and people. Preventive use will be limited to individual animals and allowed only when justified by a veterinarian. Group treatment of animals will only be allowed in an exceptional case where the risk of bacterial infection or disease is high, and no other treatment alternative is available. These rules are also extended to apply to imported foodstuffs.
Proposals not based on animal health expertise aiming at completely banning certain antimicrobials to treat animals, even when no suitable alternative is available, present a serious threat to animals’ health. Therefore, we look forward to continuing our active cooperation with legislators, EU and national agencies, and other stakeholders to increase understanding of the scientific evidence and risk-benefit evaluation to protect the well-being of animals.
Elsa Vecino, DVM, technical director